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01 6Janssen-Cilag

02 3Johnson & Johnson Innovative Medicine

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PharmaCompass

01

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Bedaquiline

Brand Name : Sirturo

Dosage Form : Bedaquilina 100Mg 188 Unita' Oral Use

Dosage Strength : 188 CPR 100 mg bottle

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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02

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Bedaquiline

Brand Name : Sirturo

Dosage Form : Antic-calc Tablet

Dosage Strength : 100 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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03

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Bedaquiline Fumarate

Brand Name : Sirturo

Dosage Form : Tablet

Dosage Strength : 100mg

Packaging :

Approval Date : 05/03/2014

Application Number : 20120908000088

Regulatory Info : Approved

Registration Country : Sweden

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04

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Bedaquiline Fumarate

Brand Name : Sirturo

Dosage Form : Tablet

Dosage Strength : 20mg

Packaging :

Approval Date : 26/03/2021

Application Number : 20191127000036

Regulatory Info : Approved

Registration Country : Sweden

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05

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Bedaquiline Fumarate

Brand Name : Sirturo

Dosage Form : Tablet

Dosage Strength : 100MG

Packaging :

Approval Date : 2015-09-10

Application Number : 113901002

Regulatory Info : Authorized

Registration Country : Spain

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06

PREP
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Bedaquiline Fumarate

Brand Name : Sirturo

Dosage Form : Tablet

Dosage Strength : 100MG

Packaging :

Approval Date : 2014-09-18

Application Number : 113901001

Regulatory Info : Authorized

Registration Country : Spain

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07

PREP
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BEDAQUILINE FUMARATE

Brand Name : SIRTURO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Packaging :

Approval Date : 2012-12-28

Application Number : 204384

Regulatory Info : RX

Registration Country : USA

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08

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BEDAQUILINE FUMARATE

Brand Name : SIRTURO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE

Packaging :

Approval Date : 2020-05-27

Application Number : 204384

Regulatory Info : RX

Registration Country : USA

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09

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Bedaquiline

Brand Name : SIRTURO

Dosage Form : CAP

Dosage Strength : 100mg

Packaging : 188X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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